Alterations In Laboratory Tests Research Articles

Evaluation of Ornidazole Tablets Bioequivalence in Chinese Healthy Participants Under Fasted and Fed Conditions Using Pharmacokinetic Parameters.

Ornidazole, the third generation of nitroimidazole derivatives after metronidazole and tinidazole, it exerts both bactericidal and antiprotozoal effects. The purpose of this study was to evaluate the pharmacokinetic and bioequivalence of two ornidazole tablets manufactured by two different manufacturers based on their pharmacokinetic parameters. Fasted and fed healthy Chinese volunteers participated in a randomized sequence, single-dose, open-label, two-period crossover trial. There were 24 participants in both the fed studyand the fastedstudy. Following a 7-day washout period before receiving the alternative formulation, eligible research participants were randomly assigned (1:1) to receive a single dosage of either the reference formulation or the test formulation. Following tablet administration, plasma samples were obtained over 72 h and analyzed using liquid chromatography tandem mass spectrometry (LC-MS/MS) to evaluate ornidazole contents. maximum plasma concentration (Cmax), time to Cmax (Tmax),the area under the curve (AUC) from t = 0 to infinity (AUC0-∞), AUCfrom t = 0 to the last quantifiable concentration (AUC0-t), half-life (t1/2),and terminal elimination rate constant (z) were evaluated as pharmacokinetic (PK) parameters. The safety evaluation involved adverse events (AEs) incidence and alterations in laboratory tests (hepatic function, blood biochemistry, hematology, and urinalysis) or vital signs (temperature, pulse, and blood pressure). For the bioequivalence assessment in the fast trial, the prime PK parameters comparison between the reference and test formulation revealed that the GMR (90% CI) values for AUC0-t, Cmax, and AUC0-∞ were 100.97% (99.12-102.85%), 99.88% (90.63-110.08%), and 101.12% (99.17-103.11%), respectively. For the bioequivalence assessment in the fed trial, the key PK parameters comparison between the reference and test formulations revealed that the GMR (90% CI) values for AUC0-t, Cmax, and AUC0-∞ were 103.00% (100.94-105.11%), 101.90% (99.63-104.22%), and 102.99% (100.87-105.16%), respectively. The geometric mean ratios (GMRs) for the primary pharmacokinetic parameters (Cmax, AUC0-72, and AUC0-∞) between the two formulations and the corresponding 90% confidence intervals (CIs) were all within the range of 80.00-125.00% for both the fasting and fed states. Both treatments have comparable safety profiles. The bioequivalence and tolerability of ornidazole tablet reference and test formulations were evaluated among healthy Chinese participants under both fasting and fed conditions. The results indicated that both formulations were bioequivalent and generally well tolerated; besides, the interaction between food and drug may affect drug pharmacokinetics. CTR20212873, registered on 15 November 2021; ChiCTR2300069098, registered on 7 March 2023.

Acne Fulminans: Management for the First Contact Physician

Acne fulminans or acne malignant is a rare skin pathology that presents in the form of painful, ulcerative, disfiguring acne, usually accompanied by systemic symptoms such as fever or polyarthralgia. Arriving even in serious cases to cause bone injuries and alterations in laboratory tests. This condition is usually resistant to the antibiotics usually administered, which is why it is so important to have a multidisciplinary team that is in coordination for the care of affected patients.

Dynamic profiles and predictive values of some biochemical and haematological quantities in COVID-19 inpatients.

IntroductionSevere acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in some hospitalized patients has shown some important alterations in laboratory tests. The aim of this study was to establish the most relevant quantities associated with the worst prognosis related to COVID-19.Materials and methodsThis was a descriptive, longitudinal, observational and retrospective study, in a cohort of 845 adult inpatients from Bellvitge University Hospital (L’Hospitalet de Llobregat, Barcelona, Spain). A multivariate regression analysis was carried out in demographic, clinical and laboratory data, comparing survivors (SURV) and non-survivors (no-SURV). A receiver operating characteristic analysis was also carried out to establish the cut-off point for poor prognostic with better specificity and sensibility. Dynamic changes in clinical laboratory measurements were tracked from day 1 to day 28 after the onset of symptoms.ResultsDuring their hospital stay, 18% of the patients died. Age, kidney disease, creatinine (CREA), lactate-dehydrogenase (LD), C-reactive-protein (CRP) and lymphocyte (LYM) concentration showed the strongest independent associations with the risk of death in the multivariate regression analysis. Established cut-off values for poor prognosis for CREA, LD, CRP and LYM concentrations were 75.0 μmol /L, 320 U/L, 80.9 mg/L and 0.69 x109/L. Dynamic profile of laboratory findings, were in agreement with the consequences of organ damage and tissue destruction.ConclusionsAge, kidney disease, CREA, LD, CRP and LYM concentrations in COVID-19 patients from the southern region of Catalonia provide important information for their prognosis. Measurement of LD has demonstrated to be very good indicator of poor prognosis at initial evaluation because of its stability over time.

Assessment of comorbidities and COVID-19 pneumonia prognosis: a literature review

Mortality due to SARS-CoV-2 is high compared to that caused by other respiratory viruses. This article aims to define the comorbidities associated with high mortality rates or complications that require ventilatory support in intensive care units. A bibliographic search has been performed with respect to comorbidities and/or alterations in laboratory tests and radiographic exams that have been associated with mortality, especially those described in China.

CLINICAL CHARACTERIZATION OF PATIENTS WITH BURNING MOUTH SYNDROME

<h3>Background</h3> Burning mouth syndrome (BMS) is a condition characterized by burning sensation in the oral mucosa, especially the tongue. It mainly affects women, severely undermining quality of life. Sometimes patients also report xerostomia, a symptom that can appear together with decrease in salivary flow, and dysgeusia. <h3>Objective</h3> To describe clinical characteristics related to patients with BMS (age, sex, location of pain, association with xerostomia or dysgeusia, emotional symptoms, unstimulated salivary flow, and alterations in laboratory tests). <h3>Methods</h3> Nineteen patients with BMS were evaluated. For data analysis, descriptive statistics and unpaired <i>t</i> tests were used. <h3>Results</h3> All patients were women, with a mean age of 61.4 years. Pain was mainly located in the anterior area of the tongue. Fourteen patients presented an additional symptom (73.7%), the most frequent being xerostomia; however, we did not find significant differences in unstimulated salivary flow with the control group. In addition, 73.7% reported feeling stressed, anxious, and/or depressed, and only 5 patients presented an altered laboratory test (26.3%). <h3>Conclusions</h3> BMS is a pain disorder that affects quality of life; the psychological profile is an important aspect to consider in our evaluation because some patients may need a referral for psychological therapy.

Cyclooxygenases 1 and 2 inhibition and analgesic efficacy of dipyrone at different doses or meloxicam in cats after ovariohysterectomy

ObjectiveTo evaluate the cyclooxygenases (COX) inhibition, adverse effects and analgesic efficacy of dipyrone or meloxicam in cats undergoing elective ovariohysterectomy. Study designProspective, blinded, randomized, clinical study. AnimalsA total of 30 healthy young cats. MethodsThe cats were randomly assigned to three postoperative groups: D25 (dipyrone 25 mg kg−1 every 24 hours), D12.5 (dipyrone 12.5 mg kg−1 every 12 hours) and M (meloxicam 0.1 mg kg−1 every 24 hours). In the first 24 hours, the drugs were administered intravenously (IV), and then orally for 6 (dipyrone) or 3 days (meloxicam). Prostanoids thromboxane B2 and prostaglandin E2 concentrations served as indicators of COX activity and, with physiological variables and pain and sedation scores, were measured for 24 hours after first analgesic administration. Rescue analgesia (tramadol, 2 mg kg−1 IV) was provided if Glasgow feline composite measure pain scale (CMPS-Feline) ≥5. Laboratory tests included symmetric dimethylarginine and adverse effects were evaluated regularly up to 7 and 10 days after surgery, respectively. Parametric and nonparametric data were analyzed with two-way anova and Kruskal-Wallis tests, respectively (p < 0.05). ResultsIn the first half hour after analgesic administration, COX-1 activity was close to zero and remained significantly lower than before drug administration for 24 hours in all groups. The inhibition of COX-2 activity was significant for 30 minutes in all groups and up to 4 hours in group M. No alterations in laboratory tests or significant adverse effects were observed. Pain scores and need for rescue analgesia did not differ statistically among groups. ConclusionsDipyrone at both doses and meloxicam provided a nonselective inhibition of COX-1 and -2 activities and effective analgesia without causing significant adverse effects or laboratory tests alterations. Clinical relevanceDipyrone at both doses provides equally effective analgesia without causing adverse effects in cats undergoing ovariohysterectomy.

EVALUATION OF POSTEXODONTIC BLEEDING IN PATIENTS RECEIVING ANTICOAGULANT THERAPY WITH LOW-MOLECULAR-WEIGHT HEPARIN: PILOT STUDY

Objective: To evaluate the volume of bleeding during exodontia and postoperative hemorrhagic complications in patients using low-molecular-weight heparin (LMWH). Study Design: Ten patients receiving LMWH (study group), 40 mg, once daily, were operated on compared to the control group composed of 10 patients not receiving heparin. Molar teeth were extracted, using a local anesthetic with vasoconstrictor, and a local hemostatic medium was used. Results: We did not observe alterations in laboratory tests in both groups, showing that LMWH does not alter routine laboratory exams. The mean blood volume lost during the exodontia was 0.12 mL per minute for patients using LMWH, and 0.1 mL per minute control group composed by health patients. There were no postoperative hemorrhagic complications in both groups (bleeding, hematoma, or blood transfusion). Conclusion: There was no change in laboratory tests during the use of LMWH. There was little loss in blood volume compared with the control group, as well as the absence of postoperative complications in patients using LMWH, and it was not necessary to suspend the drug for dental procedures. Objective: To evaluate the volume of bleeding during exodontia and postoperative hemorrhagic complications in patients using low-molecular-weight heparin (LMWH). Study Design: Ten patients receiving LMWH (study group), 40 mg, once daily, were operated on compared to the control group composed of 10 patients not receiving heparin. Molar teeth were extracted, using a local anesthetic with vasoconstrictor, and a local hemostatic medium was used. Results: We did not observe alterations in laboratory tests in both groups, showing that LMWH does not alter routine laboratory exams. The mean blood volume lost during the exodontia was 0.12 mL per minute for patients using LMWH, and 0.1 mL per minute control group composed by health patients. There were no postoperative hemorrhagic complications in both groups (bleeding, hematoma, or blood transfusion). Conclusion: There was no change in laboratory tests during the use of LMWH. There was little loss in blood volume compared with the control group, as well as the absence of postoperative complications in patients using LMWH, and it was not necessary to suspend the drug for dental procedures.

Laboratory test alterations in patients with COVID-19 and non COVID-19 interstitial pneumonia: a preliminary report.

Coronavirus disease 19 (COVID-19) is the greatest pandemic in modern history. Laboratory test alterations have been described in COVID-19 patients, but differences with other pneumonias have been poorly investigated to date, especially in Caucasian populations. The aim of this study was to investigate differences and prognostic potential of routine blood tests in a series of Italian patients with COVID-19 and non-COVID-19 interstitial pneumonia. Clinical data and routine laboratory tests of a consecutive series of 30 COVID-19 patients and 30 age and sex matched patients with non COVID-19 interstitial pneumonia have been retrospectively collected. Differences in laboratory tests between patients with COVID-19 and non COVID-19 pneumonias have been investigated, as well as differences between COVID-19 survivors and non survivors. COVID-19 patients had lower white blood cells, monocytes, neutrophils, and higher platelet counts. In addition, COVID-19 patients showed higher mean platelet volume, lower C reactive protein concentrations, and higher De Ritis ratio. Combined blood cell indexes of systemic inflammation were significantly lower in COVID-19 patients. In further analysis of the COVID-19 group, the neutrophil count, neutrophil to lymphocyte ratio (NLR), derived NLR, systemic inflammation response index and De Ritis ratio, were significantly higher in non survivors than in survivors, while the number of platelets was significantly lower in non survivors. Our study showed several alterations in blood cell populations and indexes in patients with COVID-19 pneumonia in comparison with patients with non COVID-19 pneumonia. Some of these indexes showed promising prognostic abilities. Further studies are necessary to confirm these results.

Care of patients with liver disease during the COVID-19 pandemic: EASL-ESCMID position paper.

SummaryThe coronavirus disease 2019 (COVID-19) pandemic poses an enormous challenge to healthcare systems in affected communities. Older patients and those with pre-existing medical conditions have been identified as populations at risk of a severe disease course. It remains unclear at this point to what extent chronic liver diseases should be considered as risk factors, due to a shortage of appropriate studies. However, patients with advanced liver disease and those after liver transplantation represent vulnerable patient cohorts with an increased risk of infection and/or a severe course of COVID-19. In addition, the current pandemic requires unusual allocation of healthcare resources which may negatively impact the care of patients with chronic liver disease that continue to require medical attention. Thus, the challenge hepatologists are facing is to promote telemedicine in the outpatient setting, prioritise outpatient contacts, avoid nosocomial dissemination of the virus to patients and healthcare providers, and at the same time maintain standard care for patients who require immediate medical attention.

Changes in admission laboratory tests in patients with maxillofacial fractures and the influence of dento-alveolar trauma.

There are few studies in the literature evaluating possible alterations in laboratory tests in patients with maxillofacial fractures. The aim of thisstudy was to analyze the changes in admission laboratory tests of patients with maxillofacial fractures with indications for surgical treatment, including the influence of dento-alveolar trauma. Data from complete blood counts, blood coagulation tests, blood chemistries, and urinalysis results were obtained. The occurrence of concomitant dento-alveolar trauma was noted. The medical records were also re-evaluated later to verify the treatment outcome and the occurrence of complications. Statistical analyses were performed using the likelihood-ratio test to verify significant changes in the evaluated parameters (P≤.050). There was a prevalence of males (78%) with a mean age of 35.9years. Lower erythrocyte counts, hemoglobin levels, and/or hematocrit were observed in males with associated fractures and with simultaneous dento-alveolar fractures. Higher mean neutrophil, segmented neutrophil, and lymphocyte counts were observed in patients with simultaneous dento-alveolar trauma. A higher mean activated partial thromboplastin time (aPTT) ratio was also observed. Lower potassium levels were observed for patients in the fourth decade of life. Higher leukocyte counts not associated with trauma were observed in the urinalysis results of females and in the group of patients aged 20 or younger. Verification of treatment outcome showed two cases of infections and two cases that needed re-operation after mandible fractures. These four cases showed no significant changes in laboratory tests regarding the predisposition for complications. Patients with maxillofacial fractures had neutrophilia, increased aPTT, and non-traumatic leukocyturia. There was an influence of associated fractures and dento-alveolar trauma on the decrease in red blood cell parameters, neutrophilia, and lymphocytosis and of age on hypokalemia.

Current screening approaches for antibody deficiency.

Diagnostic delay is a major problem for rare diseases including primary antibody deficiency (PAD). The aim of this review is to discuss the opportunities and challenges of current and future screening approaches for antibody deficiency, to reduce the delay and its impact on patients. (Figure is included in full-text article.) Diagnostic delay in PAD is known to result in increased morbidity, mortality, and permanent functional impairment. Approaches to prevent this have been only partially successful and the delay may still be many years as the clinical presentation of PAD is highly variable and may be at any age, making screening difficult. Patients often have numerous healthcare encounters generating repeated cycles of laboratory and clinical data before the diagnosis is made. Low immunoglobulin levels result in alterations in laboratory tests not directly aimed at measuring immunoglobulins. We describe these and highlight the growing evidence in support of using calculated globulin which is part of the liver function test profile as a screening tool for antibody deficiency. Additional approaches include using embedded algorithms to analyse data generated by repeated clinical encounters (e.g. infections, antibiotics, cytopenias), potentially in combination with laboratory results such as calculated globulin, to help bring forward the diagnosis of PAD in patients in whom this has not yet been considered. There is a strong case for the use of calculated globulin in screening for antibody deficiency. Further work is required to integrate laboratory results with clinical data to reduce diagnostic delay in patients with hitherto unsuspected antibody deficiency.

Clinical and laboratory test in patients with familial amyloid polyneuropathy: differences between symptomatic patients and asymptomatic carriers

Results Out of a total of 20 patients: 14 women (70 %) with a median age of 47.5 years. All of asymptomatic carriers were diagnosed for family history and 90 % of the symptomatic patients had neurologic impairment demonstrated with pathological electroneurography (NC) (p=0.016). The symptomatic patients had higher variability of blood pressure both systolic (p=0.016) and diastolic (p=0.045) and of heart rate (p<0.005). Regarding laboratory test alterations this patients presented a decrease of free T4 (p<0.005) and an increase of cystatine C (p=0.046). As for the comparison by age-at-onset in 9 (45 %) cases the diagnosis was late-onset and 11 (55 %) early-onset. Mean age was 38.55 vs 61.56 years (p<0.005). The 63.6 % of the patients less than 50 years old were diagnosed for family history and all were asymptomatic, 62.5% of them had normal NC and 9.1 % were in clinical stage II. The late-onset in comparison with the other group had a decrease of total proteins (p=0.008) and an increase of Blood urea nitrogen (p<0.005) and cystatine C (p=0.04).

Retiform purpura caused by the use of cocaine, that was probably adulterated with levamisole.

Dear Editor: Retiform purpura is a dermatological condition characterized by reticulated, stellate, or serpentine shaped purple lesions on the skin and mucous membranes. New, multiple cases of retiform purpura after the use of levamisole adulterated cocaine have been reported. Levamisole is an anthelmintic drug with immunomodulatory and immunostimulating properties. It has been used in humans to treat rheumatoid arthritis, cancer of the colon and nephritic syndrome in children. It was withdrawn from use in the United States in 2000 because of the risk of agranulocytosis1. We report the case of a 52-year-old woman receiving treatment with levothyroxine for hypothyroidism. Two days after consuming cocaine, she developed painful skin lesions with arthralgia on both wrists. Physical examination revealed plaques and papules infiltrated to touch, purpuric on the edges and necrotic in the center, with reticular and stellate lesions on both cheeks, the tip of the nose, outer left ear, and lower limbs (Fig. 1). Biopsy revealed thrombotic vasculopathy of the small and medium blood vessels in the dermis and subcutaneous cell tissue (Fig. 2). Blood tests revealed leukopenia, neutropenia, and lymphopenia. Antinuclear antibodies (ANA, titer 1 : 1.280) in anti-neutrophil cytoplasm antibodies (ANCAs) against myeloperoxidase with a p-ANCA pattern (titer, >100 [0~5]), and ANCAs against proteinase 3 with a c-ANCA pattern (titer, 6.8 [0~5]) were also found. Hypocomplementemia of C3 was detected. The tests for thrombosis and coagulation, serology, cryoglobulins and antiphospholipid antibodies were normal or negative. Cocaine was detected in the urine sample. The results of chest radiography and urine sediment test were normal. A diagnosis of retiform purpura resulting from the use of cocaine, that was probably adulterated with levamisole was made. She was prescribed with low dose oral prednisone. The hematological symptoms cleared 5 days later, after one month, the skin lesions had healed without sequelae. Fig. 1 (A) A reticular plaque with purpuric edges and necrotic center on the left cheek. (B) Reticular and stellate plaques with purpuric edges and necrotic center on low limbs. Fig. 2 Hematoxylin-eosin staining image (×10) showing thrombotic vasculopathy of the small and medium blood vessels in the dermis and subcutaneous cell tissue. Levamisole is currently only used in veterinary medicine as an anthelmintic; however, it has recently begun to be used as an adulterant in cocaine in many countries, including Spain2. Levamisole poisoning should be suspected in the case of a young patient presenting bilateral cutaneous necrosis on the earlobes, cheeks, or nose, that may be accompanied with retiform purpura lesions, primarily on the legs3. There may also be signs of arthralgia, fatigue, and general malaise. In the literature, some cases showing convulsions, kidney failure, or pulmonary haemorrhage have also been reported. The most common alterations in laboratory tests are neutropenia, a p-ANCA pattern, and the presence of antiphospholipid antibodies. More specific immune markers include antielastase antibodies. However, to confirm the diagnosis, levamisole detection in urine by using gas chromatography-mass spectrometry is required. However, most of the reported cases, including ours, are unconfirmed. This is because of the unavailability of testing techniques4 and the short half-life of levamisole (5.5~6 h)5. Two histological patterns have been documented: leukocytoclastic vasculitis and thrombotic vasculopathy. In most patients, skin lesions resolve spontaneously 2~3 weeks after stopping levamisole. However, the serological alterations may persist for up to 14 months3.

A randomized and controlled trial about the use of oral isotretinoin for photoaging

Topical retinoids are used to treat photoaging; oral isotretinoin is gold standard for acne; "off label" indications, including photoaging, have been reported with insufficient evidence of efficacy. This is a randomized controlled phase II trial with clinical and histological assessment to evaluate efficacy and safety of oral isotretinoin for photoaging. Study population was comprised of 32 menopausal or sterilized women, aged 40-55, divided in 2 groups: A (21) received 20mg isotretinoin, 3 times per week, nightly moisturizer, and daily sunscreen, for three months; B (11) just moisturizer/sunscreen. Main outcome measures were: overall clinical assessment; profilometry, corneometer and elasticity tests in periocular regions and left forearm; before/after biopsies from left forearm in patients of B and in 10 randomly selected of A. Microscopic blinded evaluation of epidermal thickness, dermal elastosis, new collagen, p53 epidermal expression was performed by quantitative digital image analysis. All data were submitted to statistical analysis. Clinical evaluation showed slight improvement; profilometry, corneometer and skin elasticity tests presented significant difference in pre/post values (P = 0.001 to 0.028), but no differences between A/B. Histological findings and p53 expression were comparable between groups before treatment (P > 0.1); microscopic analysis showed no differences between groups for most variables, after treatment. Slight but significant difference between A/B for p53 with major reduction post isotretinoin [0.66+/-0.31 vs. 0.94+/-0.34 respectively (P = 0.04) was observed. There were minor side effects and no significant laboratory test alterations. We concluded that no significant clinical, microscopic changes but p53 epidermal expression reduction were observed. The role of ultra-violet induced p53 mutation in skin carcinogenesis reinforces retinoids chemoprevention. Oral isotretinoin seemed safe but not effective to treat photoaging. Caution should be considered for women prone to pregnancy. Further controlled studies are necessary.

Anicteric cholangiopathy in schistosomiasis patients

We previously reported that in anicteric patients with the isolated form of schistosomiasis (without co-morbidities) an ursodeoxycholic acid-sensitive increase in serum gamma-glutamyltransferase activity (γGT) occurs. We now describe the presence of cholangiopathy in these patients. Methods Sixteen adult anicteric patients with the isolated form of schistosomiasis mansoni were carefully selected: nine with increased γGT and seven with normal γGT. High sensitive C-reactive protein (CRP), to exclude inflammatory status, hyaluronic acid (HA), and other laboratory parameters were determined. The ultrasonographic study measured spleen length, portal vein and splenic vein diameters, and the portal flow. Magnetic resonance cholangiopancreatography (MRCP) images were interpreted by a blind observer. MRCP was deemed abnormal when focal narrowing and/or paucity of second and third order biliary branches and/or irregularities in the contours of biliary pathways were identified. Results Both groups (normal and elevated γGT) have preserved hepatic function tests (HA, serum albumin, prothrombin time) and clinical significant portal hypertension (low platelet count and ultrasonographic parameters). MRCP was abnormal in all patients with elevated γGT but in only 3 of the 7 patients with normal γGT ( p = 0.003). Conclusion Magnetic resonance cholangiopancreatography characterized a cholangiopatic disorder in anicteric patients with the isolated form of schistosomiasis, even preceding laboratory test alterations.

Treatment of actinomycetoma due to Nocardia spp. with amoxicillin?clavulanate

Actinomycetoma is a chronic occupational condition that occurs frequently in tropical regions. In Mexico 85% of cases are caused by Nocardia brasiliensis. There are two treatments of choice for these cases: a regimen of dapsone plus trimethoprim-sulfamethoxazole (co-trimoxazole) and, recently, amikacin, either alone or combined. However, not all cases respond properly to these therapies. To report a retrospective, 11-year study of cases of actinomycetomas caused by Nocardia spp., treated with amoxicillin-clavulanate (co-amoxiclav). All cases were identified clinically and microbiologically and had previously failed standard therapies. Oral co-amoxiclav 875/125 mg was administered every 12 h. Clinical, microbiological and laboratory follow up was performed every 2 months during the treatment period. Twenty-one cases of actinomycetoma were included, 19 caused by N. brasiliensis and one each by N. asteroides and N. otitidiscaviarum. Clinical and microbiological cure occurred in 15 of 21 cases (71%); two cases improved (10%) and four failed (19%). Mean treatment period was 9.6 months, during which neither side-effects nor laboratory test alterations were reported. Treatment with co-amoxiclav represents an alternative or rescue treatment for cases that have previously failed standard therapies.

Epidemiological, biological and histological characterization of patients with indeterminate third‐generation recombinant immunoblot assay antibody results for hepatitis C virus

We studied the epidemiological, laboratory and histological characteristics of a group of patients with positive antibodies against hepatitis C virus (HCV) as determined by third-generation enzyme-linked immunosorbent assay (ELISA), and with indeterminate HCV antibody positivity as established by third-generation recombinant immunoblot assay (RIBA-3). The results obtained were compared with those recorded in a group of RIBA-3-positive patients. Both groups correspond to blood donors in whom the prevalence of hepatitis C is low. There were no statistically significant intergroup differences in mean age, or in the presence of infection risk factors. RNA positivity was much more frequent in the RIBA-positive group (71%vs 10%; P < 0.05), as was transaminase elevation during the 3 years of follow-up (54%vs 13%; P < 0.05). In 46% of the RIBA-indeterminate patients the liver biopsy proved normal, or only liver steatosis or minimal changes were detected, while 33% had persistent chronic hepatitis, and 21% showed active chronic hepatitis. A mean Knodell index score of 2.28 was recorded; 50% of the subjects showed no fibrosis, 46% grade 1 fibrosis (fibrous portal expansion), 4% grade 2 fibrosis (bridging fibrosis), and none grade 3 fibrosis (liver cirrhosis). In the RIBA-positive group, a greater percentage of patients had active chronic hepatitis, a greater Knodell index, and increased-grade fibrosis. It can be concluded that the RIBA-3-indeterminate group is epidemiologically similar to the RIBA-3-positive series, although with a lesser prevalence of laboratory test alterations, a lower viral replication index, and more likely to have benign disease - particularly in subjects without viral replication.

Double Duplication in a Nonrotational Colon Study of a Case Associated with Mucinous Adenoma

Duplications of gastrointestinal tract are unusual anomalies, especially in the colon. We report a case with two colonic duplications in a 20 year old woman who complained of recurrent backache associated with left lower quadrant abdominal pain. Neither physical examination nor laboratory test alterations were detected. Roentgenographic examination showed organic scolinosis, no intestinal gas and a mass with central hyperdensity and thickened wall in the descending colon area on the CT scan. Laparotomy was performed in which 22 cm of ascending colon and terminal ileum sited on left side, was excised. Pathological study revealed two unrelated and cystic duplications without communication to intestinal lumen. Their epithelial lining were of colonic or gastric types and showed a mucinous adenoma; the remaining layers were normal except for eosinophilic inflammatory infiltrate with Charcot-Leyden like crystaloids. In conclusion, we present a double spherical colonic duplication type I associated to a mucinous adenoma on a non-rotational ascending colon in a patient with organic scoliosis.

Tolerability and efficacy of combination therapy with simvastatin plus gemfibrozil in type IIb refractory familial combined hyperlipidemia

Type IIb hyperlipidemia due to familial combined hyperlipidemia (FCH) is a common lipid metabolism disorder associated with a high incidence of coronary heart disease. Simvastatin and gemfibrozil are two drugs commonly used to treat this lipid abnormality. However, monotherapy with these drugs often fails to reduce serum cholesterol and triglycerides to optimal levels. In this study the tolerability and efficacy of combined simvastatin plus gemfibrozil therapy was investigated over 18 months in 20 patients (15 men and five women, ages 42 to 71 years) at high risk for atherosclerosis affected by type IIb FCH. Patients were selected because they did not respond satisfactorily to monotherapy with simvastatin or gemfibrozil, taken for at least 6 months with no side effects, namely laboratory test alterations or subjective complaints. The administration protocol was designed as a three-phase open study. In the first phase (8 weeks) patients were assigned to take 10 mg/day simvastatin plus 600 mg/day gemfibrozil; in the second phase (4 months) variable doses of simvastatin [10 to 20 mg/day, depending on the decrease in low-density lipoprotein (LDL) cholesterol] and gemfibrozil (600 to 1200 mg/day, depending on serum triglyceride values) were prescribed. In the follow-up period (phase 3) optimum therapy was maintained. No patient dropped out of the study, and no side effects were recorded. Serum creatine phosphokinase remained within the normal range, as did other hematochemical tolerability parameters. At the end of the follow-up, total (TC) and LDL cholesterol dropped by 35% (from 334 ± 38 mg/dl to 218 ± 27 mg/dl, P < 0.0001) and 39% (from 230 ± 36 mg/dl to 141 ± 29 mg/dl, P < 0.0001), respectively. Total serum triglycerides decreased from 332 ± 45 mg/dl to 166 ± 44 mg/dl (−50%, P < 0.0001), whereas high-density lipoprotein (HDL) cholesterol increased by 16% (from 38 ± 7 mg/dl to 43 ± 7 mg/dl, P < 0.0001). The TC to HDL cholesterol ratio decreased from 9.1 ± 1.7 to 5.3 ± 1 ( P < 0.0001). In six cases the therapy was able to normalize the lipoprotein profile and in others an obvious benefit of combination therapy versus monotherapy was evident. In conclusion, with the precaution of a careful selection of patients, simvastatin plus gemfibrozil administration may be a well-tolerated and effective therapy when drastic reduction of atherogenic lipoproteins is needed in high-risk patients. However, we do not recommend general use of such a combination, which must only be initiated under close medical supervision in a specialized center, since myopathy, rhabdomyolysis, and renal failure have been reported in other studies.

Reference Materials for the Practice of Adolescent Medicine

Clinically useful data for the practice of adolescent medicine are presented in tabular format, and include norms for growth and development, laboratory test alterations during puberty, and information on contraceptives and gynecologic care.